FDA.reportPublic FDA data

Protemp™ Plus

Primary DI
J001702011374140
Brand
Protemp™ Plus
Company
3M Deutschland GmbH
Model
46962
Catalog number
46962
Device description
3M™ ESPE™ Protemp™ Plus Temporization Material Intro Kit A2, 46962
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN
EBGCROWN AND BRIDGE, TEMPORARY, RESIN
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
EMACEMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2
EIDSyringe, Restorative And Impression MaterialDental1
EMACement, DentalDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J001702011374140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fatty acid dental cementA non-sterile, non-aqueous substance containing fatty acids typically with a mixture of oxides or hydroxides of zinc, magnesium, and/or calcium, that cures upon the acid/base reaction of its components and is intended to be used in a professional setting for the temporary luting of prefabricated dental crowns and bridges, but may also be used for the temporary filling of small cavities. It is typically available as a two-component device that can be hand mixed or auto-mixed (using a dispenser with mixing nozzle) into a paste. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
315731711
Device count
1
Lot or batch
true
Expiration date on label
true

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507073878180553M™ Tegaderm™1688NS1688NS2026-05-08
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507073878180793M™ Tegaderm™1683NS1683NS2026-05-08
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